Director s Report to the National Advisory Council on Drug Abuse

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1 Director s Report to the National Advisory Council on Drug Abuse September 4, 2013 Nora D. Volkow, M.D., Director

2 Director s Report to the National Advisory Council on Drug Abuse Budget Update What s HHS/NIH? Recent NIDA Activities & Events

3 NIDA BUDGET (Thousands) 2012 Actuals 2013 Operating Level 2014 PB NonAIDS $733,076 $691,816 $739,326 AIDS $319,292 $300,749 $332,286 TOTAL $1,052,368 $992,565 $1,071,612

4 Director s Report to the National Advisory Council on Drug Abuse Budget Update What s HHS/NIH? Recent NIDA Activities & Events

5 The Next Great American Project Learning the Language of the Brain

6 BRAIN Initiative: Goals Accelerate development, application of innovative technologies to construct dynamic picture of brain function that integrates neuronal and circuit activity over time and space Build on growing scientific foundation neuroscience, genetics, physics, engineering, informatics, nanoscience, chemistry, mathematics, etc. to catalyze interdisciplinary effort of unprecedented scope

7 Government Agencies BRAIN Initiative: Partners FY2014 Investments $ in Millions National Institutes of Health $40 Defense Advanced Research Projects Agency $50 National Science Foundation $20 Private Organizations Allen Institute for Brain Science $60 Howard Hughes Medical Institute $30 Salk Institute for Biological Studies $28 The Kavli Foundation $4

8 NIH and BRAIN: How will it work? Plan to be developed by NIH Advisory Council to the Director BRAIN Working Group - Selected for visionary leadership, expertise - Charged with articulating scientific goals, developing plan Including timetables, milestones, costs NIH BRAIN Working Group will - Seek broad input; hold open meetings, workshops - Deliver interim report on high-priority areas for FY14 funding in summer 2013; final report, June Informed by experts across sectors and disciplines; assisted by NIH Blueprint for Neuroscience Research

9 NIH and BRAIN: NIH Working Group Cornelia Bargmann, PhD (co-chair) The Rockefeller University Bill Newsome, PhD (co-chair) Stanford University David Anderson, PhD California Institute of Technology Emery Brown, MD, PhD Massachusetts Institute of Technology Karl Deisseroth, MD, PhD Stanford University John Donoghue, PhD Brown University Peter MacLeish, PhD Morehouse School of Medicine Eve Marder, PhD Brandeis University Richard Normann, PhD University of Utah Joshua Sanes, PhD Harvard University Mark Schnitzer, PhD Stanford University Terry Sejnowski, PhD Salk Institute for Biological Studies David Tank, PhD Princeton University Roger Tsien, PhD University of California, San Diego Kamil Ugurbil, PhD University of Minnesota EX OFFICIO MEMBERS Kathy Hudson, PhD National Institutes of Health Geoffrey Ling, MD, PhD Defense Advanced Research Projects Agency John Wingfield, PhD National Science Foundation

10 NIH BRAIN Working Group: Summer Schedule DATE LOCATION FOCUS May San Francisco, CA Molecular Approaches June New York, NY Large-Scale Recording Technologies and Structural Neurobiology July Boston, MA Computation, Theory, and Big Data August Minneapolis, MN Human Neuroscience September 16 ACD Teleconference ACD Vote on interim report on highpriority areas for FY14 funding *Diversity of models and systems incorporated into each session

Features of the BRAIN Initiative Potential for wide-ranging benefits Dedicated to providing tools to enhance many areas of research Should provide methods for

11 Features of the BRAIN Initiative Potential for wide-ranging benefits Dedicated to providing tools to enhance many areas of research Should provide methods for deeper understanding of all brain disorders Impact on support for other research NIH spends approximately $5.5B on neuroscience research; BRAIN Initiative is <1%

12 NIH Initiative to Enhance Reproducibility and Transparency of Research Findings Courtesy of Dr. S. Silberberg, NINDS

Underlying issues: Poor education Poor evaluation Perverse reward incentives

13 Prinz, Schlange and Asadullah Bayer HealthCare Nature Reviews Drug Discovery 2011; 10: Problem Lack of reproducibility of published research findings. Underlying issues: Poor education Poor evaluation Perverse reward incentives Almost 2/3 of 67 in-house projects at NINDS could not replicate data published by others

14 Deficient reporting is widespread Journals: Cell Nature Science Nature Medicine Nature Genetics Nature Immunology Nature Biotechnology >500 citations Translated to human studies Hackam and Redelmeier, JAMA 2006; 14: Courtesy of Dr. S. Silberberg, NINDS

15 Addressing the Issues Ad-hoc group met to develop approaches. Discussions informed by IC efforts (e.g., NCI, NINDS). Group came to a consensus on guiding principles to address the underlying issues. Principles for Addressing Issues 1. Raise community awareness. 2. Enhance formal training. 3. Improve the evaluation of applications. 4. Protect the integrity of science by adoption of more systematic review processes. 5. Increase stability for investigators.

16 Recommendations 1. Discuss with Advisory Councils and BSCs and hold workshops to the issue of reproducibility. 2. Integrate courses on experimental design into training courses. 3. Consider options for an evaluation process of a grant. 4. Adapt NIH bio-sketch to to place PI s work into context. 5. Collaborate with scientific journals and scientific community on efforts to improve rigor. 6. Consider the advisability and approach to supporting replication/reproducibility studies or centers Elena Koustova will discuss further this afternoon

17 New Common Fund FOAs NIH Transformative Research Awards (R01) RFA-RM Due Date: October 4, Supports individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original and/or unconventional research NIH Director's New Innovator Award (DP2) RFA-RM Due Date(s): October 25, 2013, October 17, 2014 & October 16, Supports early stage investigators of exceptional creativity who propose bold and highly innovative new research approaches NIH Pioneer Award Program (DP1) RFA-RM Due Date(s): October 18, 2013, October 10, 2014 and October 9, Supports individual scientists of exceptional creativity who propose pioneering & possibly transforming approaches NIH Director's Early Independence Awards (DP5) RFA-RM Due Date: January 31, 2014 Supports exceptional investigators who wish to pursue independent research directly after completion of their terminal doctoral/research degree or clinical residency

18 Collaborative Research on Addiction at NIH (CRAN) Susan Weiss will be presenting an update this afternoon

19 Recent Functional Integration FOAs Revision Applications to Promote Collaborative Research on Addiction at NIH (CRAN): Comorbidity-Related Research (R01) RFA-DA Issued: July 15, 2013; Open Date: August 24, 2013; App. Due Date: September 24, Funds are available for revisions to augment existing R01 to help meet the goals of Collaborative Research on Addiction at NIH (CRAN) Administrative Supplements to Promote Collaborative Research on Addiction at NIH (CRAN): Comorbidity- Related Research (Admin Supp) PA Issued: July 15, 2013; Open Date: August 24, 2013; App. Due Date: September 24, Funds are available for administrative supplements to parent awards in order to help meet the goals of CRAN; namely, the support of research in cross-cutting areas of SUD and related health consequences.

20 Director s Report to the National Advisory Council on Drug Abuse Budget Update What s HHS/NIH? Recent NIDA Activities & Events

21 Results from the 2012 National Survey on Drug Use and Health 68,309 respondents in 2012

22 Past Month Use of Selected Illicit Drugs among Persons Aged 12 or Older: Percent Using in Past Month Illicit Drugs Marijuana Psychotherapeutics Cocaine Hallucinogens + Difference between this estimate and the 2012 estimate is statistically significant at the.05 level.

23 Daily or Almost Daily Marijuana Use in the Past Year and Past Month among Persons Aged 12 or Older: Numbers in Millions Used Marijuana on 20 or More Days in the Past Month Used Marijuana on 300 or More Days in the Past Year Difference between this estimate and the 2012 estimate is statistically significant at the.05 level.

24 Changes in Marijuana Policy in the USA

Odds Ratio Map Of States That Legalized Marijuana By 2004 passed laws legalizing MJ 2.5 2 1.

5 0 Past Year MJ Abuse/Dependence Past Year MJ Use Past Year MJ Abuse/Dependence Among

25 Odds Ratio Map Of States That Legalized Marijuana By 2004 passed laws legalizing MJ Outcomes of Interest Past Year MJ Abuse/Dependence Past Year MJ Use Past Year MJ Abuse/Dependence Among Current Users NESARC: National Epidemiologic Survey on Alcohol and Related Conditions Cerda M et al. Drug and Alcohol Dependence 2012; 120:

26 As of now 20 states in the USA have approved the legalization of medical marijuana Research on Marijuana Legalization in the US (Admin Supp) P A Open date(s): April 30, Application due date(s): May 31, 2013 Availability of supplements to inform social, behavioral, and public health impacts of recent US marijuana legalization policies.

27 NIDA Marijuana Portfolio Discussion May 23, 2013 NIDA s Marijuana research portfolio was discussed from basic science through services and policy research. Discussion focused on: The most urgent research questions: Prospective studies in children adolescents to evaluate effects of marijuana exposure on brain development and opportunity to integrate across studies of brain development. Need to characterize the cannabinoids involved in marihuana s effects Treatment and prevention studies Policy research

Activated b 2 - ARs in Plasma Membrane & Endosomes Internalized b 2 -ARs

28 Canonical GPCR Signalling Occurs Endosomes: assessment with conformational biosensors (single-domain antibodies or nanobodies) Nb80 GFP Detects Activated b 2 - ARs in Plasma Membrane & Endosomes Internalized b 2 -ARs Contribute to camp response R Irannejad et al. Nature 000, 1-5 (2013) doi: /nature12000

COX-2 inactivates 2-AG and AEA to produce prostaglandin-glycerol esters and ethanolamides.

29 Cyclooxygenase-2 (COX-2) Modulate Endocannabinoids (ecb): in vivo COX-2 catalyze formation of prostaglandins from arachidonic acid; target of NSAIDs. COX-2 inactivates 2-AG and AEA to produce prostaglandin-glycerol esters and ethanolamides. Evidence for the in vivo regulation of ecbs by COX-2 is lacking LM-4131 mirrored PF-3845 (FAAH inhibitor) in anxiety measures POTENTIAL OF COX-2 INHIBITORS FOR THE TREATMENT OF MARIHUANA ADDICTION Hermanson et al., Nature Neuroscience 16, (2013)

30 Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependence Phase II Study Design: Endpoint Classification: Masking: Allocation: Randomized Safety/Efficacy Study 12-weeks Double Blind Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Once-Weekly Intra-Muscular Injections of TV-1380 (150 mg/week or 300 mg/week) as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects Study Status: Currently recruiting participants Estimated Study Completion Date: October 2014 Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

New Treatment FOAs Grand Opportunity in Medications Development for SUD (U01) PAR-13-270.

31 New Treatment FOAs Grand Opportunity in Medications Development for SUD (U01) PAR Issued: July 11, 2013; Open Date: February 27, 2013: Application due date(s): March 27, 2014, July 28, 2014, March 27, 2015, July 28, 2015, March 28, 2016, July 28, 2016 To accelerate the development of medication for SUD by encouraging research to support a diverse array of preclinical and/or clinical research s. Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01) PAR Issued: August 19, 2013; Open Date: February 27, 2014; Application due date(s): March 27, 2014, July 28, 2014, March 27, 2015, July 28, 2015, March 28, 2016, July 28, 2016 To support research that advances compounds towards FDA approval by leveraging resources of outside organizations, such as pharmaceutical and biotechnology companies, private and public foundations, and small businesses.

32 NIDA FOA Abuse-Resistant and Abuse-Deterrent Formulations and Devices to Avoid the Abuse, Misuse and Diversion of Prescription Opioids by Patients (SBIR)(R43/R44) RFA-DA Issued: July 15, 2013; Open date(s): September 11, 2013; Application Due Date: October 11, Represents a focused effort of NIDA on preventing diversion and misuse of prescription opioids at the patient level. Among potentially important steps towards the goal of safer opioid analgesics are the efforts to reformulate medication so that an individual would not be able (abuse resistance) or would not want (abuse deterrence) to divert the prescription drug, and to create innovative medication dispensing devices/gadgets

age and year) active IDU (C, V) incarceration (C, V) no regular primary care (C) no provider

33 Longitudinal Changes in Engagement in Care & Viral Suppression for HIV-infected IDU Predictors of lapses in care (C) & virologic failure (V) (adj. age and year) active IDU (C, V) incarceration (C, V) no regular primary care (C) no provider constancy (C, V) no health insurance (C) alcohol use (V) crack use (V) Westergaard RP et al., AIDS 2013, Jun 13. [Epub ahead of print]

2013 Avant-Garde Awards Warner Greene, M.D.

Yale University, NH, Connecticut Host genetic control of HIV CD4 T cells die of an inflammatory programmed cell death (pyroptosis), which involves caspase-1

34 2013 Avant-Garde Awards Warner Greene, M.D., Ph.D. Gladstone Institutes, SF, CA HIV without AIDS: A radically different approach to help the developing world Richard Sutton, M.D., Ph.D. Yale University, NH, Connecticut Host genetic control of HIV CD4 T cells die of an inflammatory programmed cell death (pyroptosis), which involves caspase-1 activation. Caspase-1 inhibitors are already in clinical trials and this study will use the SIV model to explore whether they can alter rates of CD4 T-cell loss and progression to AIDS. Whole exome sequencing of elite controllers and members of their families to identify genetic factors responsible for host control of HIV. Candidate genes identified from WES will be subjected to in vitro functional studies. Timothy Cardozo, M.D., Ph.D. NYU Langone Medical Center Combined cocaine and HIV vaccine Combined cocaine and HIV vaccine based on a common protein scaffold Aimed to develop an immunogen capable of eliciting HIV-protective antibodies.

New HIV/AIDS FOAs FY14 NIDA Avant-Garde Award Program for HIV/AIDS Research (DP1) RFA-DA-14-008 Issued: May 30, 2013; Open date: October 6, 2013; Application due date(s): November 6, 2013.

35 New HIV/AIDS FOAs FY14 NIDA Avant-Garde Award Program for HIV/AIDS Research (DP1) RFA-DA Issued: May 30, 2013; Open date: October 6, 2013; Application due date(s): November 6, To support individual scientists of exceptional creativity who propose high-impact research. Integrating Substance Abuse Prevention and Treatment within HIV/AIDS Service Delivery Settings (R01) RFA-DA Issued: June 10, 1013; Open date: October 15, 2013; Application due date(s): November 15, Applications to test implementation strategies for integrating evidence-based SUS services with HIV care (including sexually-transmitted infection [STI] clinics) where screening for drug and alcohol problems can be integrated with screening for HIV and other conditions.

Society for Neuroscience (SfN) Annual Meeting San Diego, CA - November 9-13, 2013 November 8 -

Therapeutics Advances in High Resolution & Large Scale Imaging of Brain Networks & Circuits The

Exhibit Booth November 11 NIDA workshop* Transitioning Beyond the Postdoc: Workshop for Early

36 Society for Neuroscience (SfN) Annual Meeting San Diego, CA - November 9-13, 2013 November 8 - Frontiers in Addiction Research Mini-Convention* Emerging & Novel Aspects of Neuronal Transmission The Jacob P. Waletzky Memorial Lecture Extracellular RNAs in Neuroscience: Biology, Biomarkers, & Therapeutics Advances in High Resolution & Large Scale Imaging of Brain Networks & Circuits The Role of the Basal Ganglia in Addiction November 9-13 NIDA participating in the NIH Neuroscience Exhibit Booth November 11 NIDA workshop* Transitioning Beyond the Postdoc: Workshop for Early Career Investigators November 12 NIDA mini-symposium* New Insights into the Specificity& Plasticity of Reward & Aversion Encoding in the Mesolimbic System. * Pending official approvals

37 Insufficient reporting of methodological approaches is evident for pre-clinical studies Adapted from Dr. S. Silberberg, NINDS Trends Neurosci 2007; 30:

38 New HIV/AIDS FOAs HIV/AIDS and Substance Use among Black/African American Women and Young MSM (R01) RFA-DA Issued: June 10, 2013; Open date: October 15, 2013; Application due date(s): November 15, Seeks applications 1) to conduct research that expands our understanding of the intersection between SUD & HIV among AA women & young AA MSM to develop &test interventions that improve HIV prevention and care s. HIV/AIDS and Substance Use Among the Homeless and Unstably Housed (R01) RFA-DA Issued: June 10, 2013; Open date: October 15, 2013; Application due date(s): November 15, Encourages studies on the development, implementation, evaluation, and dissemination of effective HIV-prevention interventions, research related to the epidemiology of HIV and SUD, and health services in prevention and treatment services for the homeless s.

NIAAA DIRECTOR S REPORT

NIAAA DIRECTOR S REPORT ON INSTITUTE ACTIVITIES TO THE 134 TH MEETING OF THE NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM Kenneth R. Warren, Ph.D. Acting Director National Institute on Alcohol